Healthy Japanese subjects
Conditions
Interventions
Duration: 4 weeks Test food: Allium victorialis subsp. platyphyllum extracts capsule Administration: Take 2 capsules with water after breakfast without chewing. *If you feel your body gets too wa
Sponsors
ORTHOMEDICO Inc.
Medical Corporation Seishinkai, Takara Clinic
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Healthy subjects 2. Subjects who are older than 40 years 3. Subjects whose basal body temperature on awakening is 35.6 degrees celsius or more and less than 36.5 degrees celsius 4. Subjects who are judged as eligible to participate in the study by the physician 5. Subjects who have relatively low basal body temperature on awakening at 1 week before screening (before consumption) 6. Subjects who showed relatively small AUC of palmar skin temperature before and after cold water load at screening (before consumption)
Exclusion criteria
Exclusion criteria: 1. Subjects who are undergoing medical treatment or have a medical history of malignant tumor, heart failure, myocardial infarction, and sinus tachycardia. 2. Subjects who have a pacemaker or an implantable cardioverter defibrillator (ICD). 3. Currently undergoing treatment for any of the following chronic diseases: cardiac arrhythmia, liver disease, kidney disease, cerebrovascular disorder, rheumatism, diabetes mellitus, dyslipidemia, hypertension, hypothyroidism, or any other chronic diseases. 4. Subjects who are undergoing medical treatment of blood disorders. 5. Subjects who are undergoing medical treatment of anemia. 6. Subjects who use or take "Foods for Specified Health Uses", "Foods with Function Claims", or other functional food/beverage in daily. 7. Subjects who are currently taking medications (including herbal medicines) and supplements. 8. Subjects who drink alcoholic beverages to excess {Average amount of alcohol intake is approximately 60 g per day converted into absolute alcohol (approximately 540 mL of Japanese sake, 3 cans (500 mL/can) of beer, or 300 mL of distilled spirits)} 9. Subjects who cannot immerse their hands in water during the cold season (Those who change their fingertips purple or white when they are immersed in water). 10. Subjects who are allergic to medicines and/or the test food related products. 11. Subjects who are pregnant, lactation, or planning to become pregnant. 12. Subjects who have been enrolled in other clinical trials within the last three months before the agreement to participate in this trial or plan to enroll in anther clinical trial during trial period. 13. Subjects who are ineligibility to participate in the study based on the evaluation of the principal physician.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Basal body temperature on awakening * Measure daily body temperature on awakening from 1 week before screening (before consumption) * Measure daily body temperature on awakening from the start consumption to the day before 4-week examination. * Assess the average body temperature on awakening per week. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Palmar Skin Temperature 2. Subjective symptoms (the Likert scale) * Measure the values before and after cold water load at screening (before consumption) and 4 weeks after consumption and calculate the amount of change. | — |
Countries
Japan
Contacts
Public ContactNaoko SUZUKI
ORTHOMEDICO Inc. R&D Department
Outcome results
None listed